Principal Medical Writer

Company: Seagen
Location: South San Francisco
Posted on: May 3, 2021

Job Description:

DescriptionSummary:The Principal Medical Writer will be responsible for independently authoring and revising clinical and regulatory documents for submission to the FDA and other agencies, and to lead other clinical communication efforts, including the development of abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals. The Principal Medical Writer will be expected to support multiple studies, programs, and/or indications.PrincipalResponsibilities:Includes but not limited toLeads the development and authoring of clinical protocols, clinical study reports, investigator brochures, and clinical summaries in support of regulatory filingsLeads the development and authoring of abstracts, posters, slides of clinical study data at medical congresses and the development of primary manuscripts for publication in peer-reviewed journalsProvides medical writing support for briefing documents, information requests, nonclinical summaries, and additional documents intended for submission to HAsFacilitates document review committee meetings and issues resolutionProvides project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documentsOrganizes, conducts, and leads cross-functional document development meetingsClosely interacts with statistics and programming departments in the development of statistical analysis plans and design of statistical outputsRoutinely engages clinical research and biostatistics to gain comprehensive understanding of compound and the design, objectives, and results of clinical trials to enable accurate and effective communication to varied audiencesRepresents medical writing on study/project teams and contributes to program strategy, through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departmentsRequiredQualifications:Minimum of 8 years of experience in the biopharmaceutical industry, with 5 years of direct medical writing experience; advanced degree(s)/academic research/transferable skills may be considered in lieu of industry experienceBA/BSPreferred Qualifications:Masters or doctorate degree in life sciencesExcellent written and verbal communication skills with the ability to interpret and present scientific dataAbility to work cross-functionallySkilled in Microsoft Word, Excel, and PowerPoint; experience with Adobe AcrobatAwareness of FDA regulations, ICH guidelines, Good Clinical Practices and the drug development processMust have the ability to independently coordinate and prioritize multiple projects in a fast-paced environmentAs the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families.Benefitsinclude medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit . Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. #LI-KO1SDL2017

Keywords: Seagen, South San Francisco , Principal Medical Writer, Other , South San Francisco, California